A prospective, observational, single-arm, open-label, multi-center, post-market clinical follow-up study to evaluate the safety and performance of the MYOSIST IAB Catheter.
试验速览
- 阶段
- Unknown
- 状态
- 招募中
- 发起方
- 入组人数
- 69
- 试验地点
- 1
研究概览
简要总结
MYOSIST™ Intra-Aortic Balloon Catheter Kit (8F): A prospective, observational, single-arm, open-label, multi-center, post-market clinical follow-up study to evaluate the safety and performance of the MYOSIST IAB Catheter.
Study Design: A prospective, single-arm, open-label, multi-center, observational, real-world, post-market clinical follow-up.
Objective: To evaluate the safety and performance of MYOSIST™ IAB Catheter.
Indication: The Intra-Aortic Balloon Catheter and accessories are used to provide counter pulsation therapy in the aorta, whereby the balloon inflates during diastole and deflates during systole, increases blood supply to the heart muscle and decreases the work of the left ventricle.
The MYOSIST™ Intra-Aortic Balloon Catheter has the following
indications for use:
Refractory Unstable Angina.
Acute Myocardial Infarction (AMI).
Impending Infarction.
Refractory Ventricular Failure.
Complications of Acute MI
Cardiogenic Shock.
Support for diagnostic, percutaneous revascularization, and interventional procedures.
Ischemia-related intractable ventricular arrhythmias.
Septic Shock.
Intraoperative pulsatile flow generation.
Weaning from cardiopulmonary bypass.
Cardiac support for non-cardiac surgery.
Prophylactic support in preparation for cardiac surgery.
Post-surgical myocardial dysfunction/low cardiac output syndrome.
Myocardial Contusion.
Mechanical bridge to other assist devices.
Cardiac support following correction of anatomical defects.
Rationale of the Study
The intra aortic balloon catheter (IABC) is a well-established mechanical circulatory support device designed to enhance coronary perfusion and reduce myocardial oxygen demand in Participants with compromised cardiac function. Despite its long-standing use, the clinical utility
of IABC remains debated, particularly in settings such as cardiogenic shock, high-risk PCI, and persistent ischemia following acute myocardial infarction. IABP features an easy implantation technique and can be rapidly deployed bedside under transthoracic or transesophageal echocardiographic guidance. This avoids the need for Participant transfer to the CathLab with the inherent risk of destabilization, and makes it an attractive approach in case of unstable hemodynamics [2]. Recent studies have produced mixed results regarding its impact on survival
and clinical outcomes, warranting further study. Despite certain advancements in technique and Participant selection, there is a need to reassess the performance and safety of IABC use in realworld clinical practice. This study aims to evaluate the hemodynamic benefits, procedural safety,
and impact on short- and long-term outcomes in Participants undergoing IABC support. Hence, the present study aims to evaluate the safety and performance of the MYOSIST™ IAB Catheter.
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 18.00 Year(s) 至 98.00 Year(s)（—）
- 性别
- All
入选标准
- •Participants having refractory unstable angina or AMI, Impending infarction or refractory ventricular failure or complication of acute MI or Cardiogenic shock.
- •Participants who require support for diagnostic or percutaneous revascularization or interventional procedures or ischemia-related intractable ventricular arrhythmias or septic shock, or intraoperative pulsatile flow generation.
- •Participants who require weaning from cardiopulmonary bypass, cardiac support for non-cardiac surgery.
- •Participants who require prophylactic support in preparation for cardiac surgery, post-surgical myocardial dysfunction cardiac output syndrome, myocardial contusion, mechanical bridge to other assist devices, and cardiac support following correction of anatomical defects.
- •The participants who are willing to be treated with the MYOSIST Intra-Aortic Balloon Catheter and accessories.
排除标准
- •Participants having aortic dissection.
- •Participants having an abdominal or aortic aneurysm.
- •Participants having aortic, iliac, or femoral vasculature with high tortuosity or calcification.
- •Participants with serious abnormal blood coagulation (based on clinical practice using INR or ACT).
- •Participants who are unwilling or unsuitable for postoperative instructions.
- •The participant who is unwilling or unable to sign the Informed Consent Document.
研究者
Dr Kiran Kumar Shetty
Meril LIfe Science Pvt. Ltd